Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device (vascular pack) used in surgical procedures. No illnesses or injuries have been reported, but the failure to confirm sterilization assurance presents a risk-of-harm: non-sterile surgical equipment could compromise patient safety and delay necessary treatment.
Plain-English summary
American Contract Systems Inc is recalling 147 Major Vascular Pack surgical kits (Model Nos. UTMV78X-01, UTMV78Y, UTMV78Y-01, UTMV78Y-02) due to inability to confirm that product sterilization assurance requirements were met.
Loss or lack of functionality in these kits may result in delayed or prolonged patient treatment. The kits are medical devices used in vascular procedures where sterility is critical to patient safety.
The recalled kits were distributed nationwide in Ohio. Lot numbers include 974241, 884241, 70-051159, 70-052011, 70-052602, and 70-053158.
The recalled product
- Product
- MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
- Manufacturer
- American Contract Systems Inc
- Affected units
- 147
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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